topcare lice treatment

Product NDC: 36800-955
11-digit product format: 368000955
Labeler code: 36800
Product ID: 36800-955_b6a41d07-8b83-4c3f-9536-257791ea3992
Type: HUMAN OTC DRUG
Nonproprietary name: Permethrin
Dosage form: LOTION
Route: TOPICAL
Labeler: Topco Associates LLC
Application: ANDA076090
Marketing category: ANDA
Marketing start: 2011-09-14
Marketing end: 0000-00-00
Substance: PERMETHRIN
Active strength: 1 mg/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-955		D	Discontinued by firm		2026-08-11
excluded package	package	36800-955	36800-955-26	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-955-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-955-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-955-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-955-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-955-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-955-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-955-26	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-955-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-955-26	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-955-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-955-26	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-955-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076090-001	PERMETHRIN	PERMETHRIN	1%	LOTION / TOPICAL			2001-12-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-955-26	ML - Milliliter	36800-955	db6a4054-312a-4048-9eae-f786aa774649	1	2018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PERMETHRIN	ACTIVE INGREDIENT	509F88P9SZ	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
PERMETHRIN	ACTIVE MOIETY	509F88P9SZ	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
BALSAM FIR LEAFY TWIG	INACTIVE INGREDIENT	H1TFV1454Z	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
CETETH-10	INACTIVE INGREDIENT	LF9X1PN3XJ	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
STEARALKONIUM CHLORIDE	INACTIVE INGREDIENT	0OUO26BB88	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE LICE TREATMENT (PERMETHRIN) LOTION [TOPCO ASSOCIATES LLC]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense lice killing creme rinse	PERMETHRIN	L. Perrigo Company	056fb377-34dd-4d33-83d7-c895b105f574	2022-11-21	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090
Topcare lice killing creme rinse	PERMETHRIN	Topco Associates LLC	3b4146a6-7c54-4dd0-9388-1e38491d16f3	2020-01-31	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
509F88P9SZ	PERMETHRIN	52645-53-1	PERMETHRIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-955-26	36800095526	2 BOTTLE in 1 CARTON (36800-955-26) > 59 mL in 1 BOTTLE	2 bottle	2011-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Lice Treatment Drug Facts	Topco Associates LLC	2017-05-25	HUMAN OTC DRUG LABEL	2